The right of the public to access documents v the right to confidentiality for marketing authorization (MA) documents: Transparency wins out in yesterday’s CJEU rulings

The CJEU delivered two rulings yesterday ( January 22, 2020) in the cases of PTC Therapeutics International v EMA case (C-175/18 P) and MSD Animal Health Innovation and Intervet International v EMA case (C-178/18 P). Read them here and here! These two rulings are of particular interest since the CJEU was for the first time asked to consider the right of access to EU documents that had been submitted in connection with an MA application.

In both cases, the European Medicines Agency (EMA) had  allowed a third party’s request of access, including toxicological reports and clinical studies. Only a very small portion of the documents had been classified as confidential. The request was granted not during the examination of the application, but rather post-MA grant and after the products were placed on the market.

The question of accessibility was raised under Regulation No 1049/2001 (find here), and the marketing authorizations concerned one product for human use (C-175/18) and one for veterinary use (C- 178/18). The EMA decision was appealed to the General Court, which dismissed both actions for annulment of the administrative grant. Both the EMA and the General Court considered that, apart from the sections that had  already been removed, the documents were not confidential and thus could be accessible to third  parties.

This Kat loooves getting hold of docs

The appellants  failed to establish that each of the elements of the report constituted commercially confidential information. The Court of Justice clarified that, in order for the documents to be considered confidential,  the risk of a protected interest being undermined had to be reasonably foreseeable and not purely hypothetical, and that one of the exceptions laid down in Article 4 of Regulation No 1049/2001 was applicable.

The General Court and the Court of Justice noted that, according to the EMA’s own policy, the EMA did not disclose commercially confidential information, such as detailed information on the quality and manufacturing of medicinal products. Therefore, even if another undertaking were to use the data contained in the report at issue, that undertaking would still have to carry out its own relevant studies and trials and successfully develop its own medicinal product.

Furthermore, the appellants had been granted 10-year market exclusivity during which no one else could  apply for a MA in the EU. Contrary to the General Court, the Court of Justice clarifies that there does not have to be any evaluation of “seriousness” as to the potential commercial harm inflicted or the exceptions provided for in Article 4 of the Regulation  No 1049/2000, and that, in that respect, the General Court committed an error of law. However, this requirement was not  decisive in the overall context   of  the ruling of the General Court and thus it is not of such importance as to justify the annulment of the decision.

The appellants claimed that documents submitted to an EU institution, agency, body or office benefit from a presumption of confidentiality. With regards to the claimed general presumption of confidentiality, the Court provided that although the institution, agency or office is permitted  to apply such  assumptions  in order to decide whether transparency of the documents would undermine the interest protected by one or more of the exceptions of Article 4 of the Regulation No 1049/2000, this is not a requirement. The general presumption of confidentiality is permissive rather than mandatory.  

Finally, regarding the appellants’ criticism that the disclosure of the reports during the data exclusivity period would seriously undermine the decision-making process, the Court of Justice ruled  that the decision-making process of relevance here was in connection with  the MA for the medicinal products involved in the  respective  cases. But this procedure was already closed at the time that the documents had been  made available.

These two cases are important for two reasons. First, they clarify an important principle in EU law, that of transparency, and second, they delineate aspects of the legal status of documents submitted in MA proceedings (and, in this connection, provide  an  interesting interpretation of Article 4 of the Regulation No 1049/2000).

In its decisions, the Court of Justice elaborated on the importance of transparency of EU documents and  confirmed that such transparency   constitutes  a foundation for the legitimacy of  EU agencies such as the EMA. The EMA, harshly criticized during the years, among other things for its lack of transparency, obviously has   a substantial interest in rulings such as the one given yesterday, which serves to enhance the broader legitimacy of its decision and  the overall role of the agency.